Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT00305656
Eligibility Criteria:
Criteria:
* AST/ALT =\< 2.5 times upper limit of normal
* Creatinine normal OR creatinine clearance \>= 60 mL/min
* Measurable contrast-enhancing tumor \>= 1 cm in longest diameter by baseline MRI or CT scan:
* Patient must have been on no steroids OR a stable dose of steroids for \>= 5 days prior to baseline MRI or CT scan
* Patients who are on steroids must be maintained on a stable corticosteroid regimen from baseline scan until the start of study treatment
* No intratumoral or peritumoral hemorrhage by MRI
* Karnofsky performance status \>= 60%
* No other concurrent malignancy within the past 5 years except curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast
* Mini-mental status examination score \>= 15
* Histologically confirmed glioblastoma multiforme
* Platelet count \>= 100,000/mm3
* Hemoglobin \>= 8 g/dL
* Bilirubin normal
* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD2171
* Mean QTc =\< 470 msec (with Bazett's correction) on screening electrocardiogram
* No history of familial long QT syndrome
* No greater than +1 proteinuria on 2 consecutive dipsticks taken \>= 1 week apart unless first urinalysis shows no protein
* No uncontrolled intercurrent illness, including, but not limited to, any of the following:
Hypertension; Ongoing or active infection; Symptomatic congestive heart failure; Unstable angina pectoris; Cardiac arrhythmia; Psychiatric illness/social situations that would limit compliance with study requirements
* No known coagulopathy that increases the risk of bleeding
* No history of clinically significant hemorrhages
* Recovered from toxicity of prior therapy
* At least 3 months since prior radiation therapy, including cranial radiation therapy
* At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)
* At least 3 weeks since prior molecularly-targeted agents
* At least 4 weeks since prior major surgery
* No more than 2 prior chemotherapy regimens or antineoplastic drugs
* More than 30 days since prior participation in an investigational trial
* At least 2 weeks since prior enzyme-inducing antiepileptic drugs (EIAEDs)
* No concurrent EIAEDs; Concurrent non-EIAEDs allowed
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other concurrent investigational agents
* No concurrent vascular endothelial growth factor inhibitors:
Prior thalidomide or lenolidomide allowed
* No concurrent anticoagulants (e.g., warfarin) or antiplatelet agents including aspirin
* No other concurrent anticancer agents or therapies
* No concurrent grapefruit juice
* WBC \>= 3,000/mm3
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Absolute neutrophil count \>= 1,500/mm3
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00305656
Study Brief:
Protocol Section:
NCT00305656